# K230009: EZ Bond Universal

- Pathway: 510(k) (Traditional)
- Applicant: Meta Biomed Co., Ltd.
- Decided: Mar 3, 2023 after 59 days
- Product code: KLE (Agent, Tooth Bonding, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K900510 (1990). 36 ancestors in all.
No later device cites it as a predicate yet.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110302: Adhesive Exl-759, 3M Espe AG (2011) Summary page 4.

## Indications for use
All classes of fillings (according to Black) with light-curing composite or compomer filling materials Repair of composite resin or compomer fillings Intraoral repair of composite restorations, porcelain fused to metal, and all-ceramic restorations without extra primer Protective varnish for glass ionomer fillings

Source page: https://510kreport.com/device/K230009
Methodology: https://510kreport.com/methodology